OKAMOTO CONDOM

Condom

OKAMOTO U.S.A., INC.

The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Okamoto Condom.

Pre-market Notification Details

Device IDK952393
510k NumberK952393
Device Name:OKAMOTO CONDOM
ClassificationCondom
Applicant OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
ContactJeffery N Gibbs
CorrespondentJeffery N Gibbs
OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-22
Decision Date1995-08-09

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